On 20-dec-2022, abbott point of care was contacted by a customer regarding i-stat eg7+ cartridges that yielded a suspected discrepant hemoglobin results on a patient with diabetic ketoacidosis and cholangitis.There was no additional patient information available at the time of this report.Patient's clinical symptoms were septic shock, acidosis, unconscious, unstable vital sign.Customer states that the patient died that night.(b)(6).At this time there is no reason to suspect a malfunction exists.The patient died as a result of complications related to septic shock, acidosis, unconscious, unstable vital sign as presented.There is no reason to suspect that the i-stat caused or contributed to the patient's demise.The reporting decision was based on information available that suggests the product was not performing within the variability of the assay.The investigation is underway.
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